STOCK TITAN

Calliditas Therapeutics Ab - CALT STOCK NEWS

Welcome to our dedicated page for Calliditas Therapeutics Ab news (Ticker: CALT), a resource for investors and traders seeking the latest updates and insights on Calliditas Therapeutics Ab stock.

Company Overview

Calliditas Therapeutics AB is a clinical-stage biopharmaceutical company devoted to developing and commercializing novel therapeutic treatments in orphan indications. With a primary focus on addressing the significant unmet medical needs in renal and hepatic diseases, the company is renowned for its cutting-edge approach in designing therapies aimed at conditions such as immunoglobulin A nephropathy (IgAN) and other rare disorders. As a pioneer in targeted therapies, Calliditas leverages an innovative platform that includes the development of controlled-release drug formulations and NOX enzyme inhibitors, making its research a significant force in rare disease treatment.

Core Business Areas

At its core, Calliditas Therapeutics AB is engaged in the identification, development, and commercialization of treatments for diseases that have limited therapeutic options. The company’s strategy is centered on the following areas:

  • Renal Therapy: With an emphasis on IgA nephropathy, the company has developed a targeted treatment regimen that aims to reduce kidney function decline, as evidenced by data from global Phase 3 clinical studies.
  • Hepatic Therapy: Recognizing the unmet needs in liver diseases, Calliditas is advancing novel treatments for conditions such as primary biliary cholangitis by refining drug formulations and treatment protocols.
  • Oncology Research: Exploration into the anti-fibrotic properties of its NOX enzyme inhibitors extends into oncological applications, addressing treatment resistance in solid tumors and expanding the company’s therapeutic reach.

Innovative Pipeline & Clinical Trials

Calliditas is distinguished by its rigorous clinical research program. The company has executed multiple clinical trials, including the landmark NefIgArd Phase 3 study, which supported full regulatory approval in key jurisdictions. The clinical development program extends into additional studies evaluating NOX enzyme inhibitors such as setanaxib in areas ranging from head and neck cancers to fibrotic liver diseases. These studies are designed to deliver robust clinical outcomes that underline the company’s focus on measurable and meaningful improvements in patient health metrics.

Regulatory Milestones & Global Collaborations

Demonstrating its commitment to clinical excellence and patient safety, Calliditas Therapeutics has achieved multiple significant regulatory milestones. The company’s therapies have received conditional approvals and are in advanced stages of regulatory review in various international markets, including top-tier jurisdictions. Strategic partnerships with global entities, such as commercial collaborations to launch innovative treatments in China and licensing agreements in Europe and Japan, further validate the company’s scientific approach and commercial potential.

Market Position & Strategic Value

Calliditas Therapeutics operates within a competitive landscape marked by the increasing demand for therapies in orphan indications. Its unique focus on rare renal and hepatic diseases allows it to address niche markets that have historically been underserved. Through focused molecular research and well-structured clinical trials, the company has established itself as a specialized entity, leveraging expertise in immunomodulation and anti-fibrotic therapies. This nuanced approach not only underscores its scientific credibility but also its ability to deliver therapeutic solutions that resonate with both healthcare providers and regulatory authorities.

Commitment to Scientific Excellence

Expertise, Experience, and Trustworthiness are evident in every aspect of Calliditas’ operations. The company’s publications in leading medical journals and its participation in prominent scientific symposia underline its dedication to advancing medical knowledge. Its strategic orientation, built on strong partnerships and an unwavering commitment to research excellence, confirms its role as an innovator in the biopharmaceutical landscape.

This comprehensive overview is crafted to provide stakeholders, analysts, and potential investors with an in-depth understanding of Calliditas Therapeutics AB, highlighting its research-driven approach, strategic market positioning, and the rigorous clinical programs that are paving the way for novel treatment paradigms in rare diseases.

Rhea-AI Summary
Calliditas Therapeutics AB (Nasdaq: CALT) announces CEO's participation in March 2024 conferences, including Carnegie Healthcare Seminar and Jefferies Biotech Summit. For more details, contact Head of IR & Sustainability, Åsa Hillsten.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
0.52%
Tags
conferences
-
Rhea-AI Summary
Calliditas Therapeutics AB (CALT) achieved full approval for TARPEYO in the US in 2023, marking a successful year. Net sales and operating income increased in Q4 2023 compared to Q4 2022. Cash decreased, but net sales and TARPEYO sales saw significant growth in 2023. The company anticipates revenue growth in 2024.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-2.96%
Tags
none
-
Rhea-AI Summary
Calliditas to release Year-end report for January - December 2023 with CEO and CFO participation. Webcast and conference call details provided.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-1.81%
Tags
none
News
Rhea-AI Summary
Calliditas Therapeutics AB (CALT) secures a new patent for TARPEYO in the US, extending product protection until 2043. The patent covers treatment of IgA nephropathy with NEFECON, showcasing the company's commitment to innovation and global expansion.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-1.64%
Tags
none
-
Rhea-AI Summary
Calliditas Therapeutics AB (CALT) provided a business update for the fourth quarter of 2023, reporting strong Q4 preliminary product revenue growth with net TARPEYO revenues of $31 – 33m for the quarter, representing significant growth over Q3. Preliminary Net TARPEYO revenues of $100 – 102m for 2023, representing over 170% year over year growth compared to 2022. Preliminary Total revenues reaching $110 – 113m for 2023, as a result of milestone payments and royalty income from the Nefecon franchise outside the US. The company also achieved a record quarter in terms of enrollments with 555 new TARPEYO prescriptions in the 4th quarter.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
3.04%
Tags
none
-
Rhea-AI Summary
Calliditas Therapeutics AB (CALT) appoints Maria Törnsén as President North America, announces full FDA approval of TARPEYO®, and targets top line read out of several Phase 2 clinical trials with setanaxib in 2024.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-- %
Tags
management
Rhea-AI Summary
Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) will present at the 42nd Annual J.P. Morgan Healthcare Conference on January 9th, 2024, providing an update on the company.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-- %
Tags
conferences
-
Rhea-AI Summary
Calliditas Therapeutics AB (CALT) secures 92 million Euro term loan with Athyrium Capital Management, LP, extending debt repayment by 3 years and ensuring continued access to non-dilutive capital. The loan will be used to fully repay the existing 68 million Euro loan with Kreos Capital, with the principal amount of the new loan being 24 million Euros greater than that of the prior facility.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-1.69%
Tags
none
-
Rhea-AI Summary
Everest Medicines (HKEX 1952.HK) licensing partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) announced that the U.S. FDA has fully approved Nefecon® delayed release capsules for adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. Nefecon® demonstrated a significant benefit over placebo in reducing kidney function loss, with a 50% less deterioration in kidney function compared to placebo over a 2-year period. The drug is also approved in China and showed a greater treatment effect in the Chinese subpopulation compared to the global population. Nefecon® is considered a revolutionary therapeutic option for IgAN patients, offering a disease-modifying treatment with sustained and clinically meaningful reduction in eGFR declines and proteinuria. The drug's approval represents a significant milestone for Everest Medicines and its partner Calliditas Therapeutics AB, with plans for a China launch in 2024.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
13.35%
Tags
none
Rhea-AI Summary
Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) announced FDA approval of TARPEYO (budesonide) to reduce kidney function loss in adults with primary IgAN. TARPEYO is the first fully FDA-approved treatment for IgAN based on a measure of kidney function, showing a 50% reduction in kidney function deterioration in TARPEYO-treated patients compared to placebo-treated patients over a 2-year period.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
13.35%
Tags

FAQ

What is the current stock price of Calliditas Therapeutics Ab (CALT)?

The current stock price of Calliditas Therapeutics Ab (CALT) is $40.0001 as of March 19, 2025.

What is the market cap of Calliditas Therapeutics Ab (CALT)?

The market cap of Calliditas Therapeutics Ab (CALT) is approximately 1.1B.

What is the primary focus of Calliditas Therapeutics AB?

Calliditas Therapeutics AB specializes in the development and commercialization of novel treatments for orphan indications, particularly in renal and hepatic diseases.

How does the company address unmet medical needs?

The company employs a research-driven approach, developing targeted therapies through rigorous clinical trials that address conditions such as IgA nephropathy and other rare disorders.

What are the key therapeutic areas for Calliditas?

The core therapeutic areas include renal therapy, notably for IgA nephropathy, hepatic therapy for liver diseases, and exploration of oncology applications through innovative NOX enzyme inhibitors.

How does Calliditas generate its revenue?

Revenue is primarily generated through the commercialization of its therapies and strategic licensing and partnership agreements in various markets, alongside milestone-driven regulatory approvals.

What distinguishes Calliditas in the biopharmaceutical industry?

Calliditas distinguishes itself by focusing on orphan diseases with significant unmet needs, leveraging innovative technology platforms and strategic global collaborations that enhance its clinical trial success and regulatory milestones.

Who are some of Calliditas' strategic partners?

The company collaborates with several global partners, including commercial and licensing agreements with leading entities in markets such as China, Europe, and Japan to expand its therapeutic reach.
Calliditas Therapeutics Ab

Nasdaq:CALT

CALT Rankings

CALT Stock Data

1.09B
27.02M
3.81%
0.32%
0.01%
Biotechnology
Healthcare
Link
Sweden
Stockholm